Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
8 giugno 2015 aggiornato da: Merck Sharp & Dohme LLC
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients
The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment.
Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
249
Fase
- Fase 2
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg
Exclusion Criteria:
- Pre-menopausal women
- patients currently taking more than two (2) blood pressure lowering medications
- Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)
- History of Alcohol abuse (<3 Years)
- History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: High BMI:MK-0736 2mg→Placebo
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
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Sperimentale: High BMI:MK-0736 7mg→Placebo
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
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Sperimentale: High BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
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Comparatore placebo: High BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
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Sperimentale: Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
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Comparatore placebo: Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration.
Mean value of the 3 measurements at the 2 timepoints was recorded.
|
Baseline and Week 12 (end of Phase A)
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Number of Participants Who Reported a Clinical Adverse Event
Lasso di tempo: 24 weeks
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE.
A clinical AE was an AE reported as a result of a clinical examination.
|
24 weeks
|
|
Number of Participants Who Reported a Laboratory Adverse Event
Lasso di tempo: 24 weeks
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE.
A laboratory AE was an AE reported as a result of a laboratory assessment or test.
|
24 weeks
|
|
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
Lasso di tempo: 24 weeks
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE.
A clinical AE was an AE reported as a result of a clinical examination.
|
24 weeks
|
|
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
Lasso di tempo: 24 weeks
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE.
A laboratory AE was an AE reported as a result of a laboratory assessment or test.
|
24 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration.
Mean trough value of the 3 measurements at the 2 timepoints was recorded.
|
Baseline and Week 12 (end of Phase A)
|
|
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration.
The mean of the 2 values at each assessment was used in analysis.
|
Baseline and Week 12 (end of Phase A)
|
|
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
Waist circumference measured in cm at baseline and after 12 weeks of study drug administration
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Baseline and Week 12 (end of Phase A)
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Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.
|
Baseline and Week 12 (end of Phase A)
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Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
HDL-C measured at baseline and after 12 weeks of study drug administration.
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Baseline and Week 12 (end of Phase A)
|
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Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Lasso di tempo: Baseline and Week 12 (end of Phase A)
|
TG measured at baseline and after 12 weeks of study drug administration
|
Baseline and Week 12 (end of Phase A)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2005
Completamento primario (Effettivo)
1 gennaio 2007
Completamento dello studio (Effettivo)
1 gennaio 2007
Date di iscrizione allo studio
Primo inviato
10 gennaio 2006
Primo inviato che soddisfa i criteri di controllo qualità
10 gennaio 2006
Primo Inserito (Stima)
11 gennaio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
3 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 giugno 2015
Ultimo verificato
1 giugno 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0736-003
- 2006_004
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